Esteem Totally Implantable Hearing System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Envoy Medical Corporation
ClinicalTrials.gov Identifier:
NCT01092910
First received: March 19, 2010
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.

Condition Intervention
Mild to Severe Sensorineural Hearing Loss
Device: Esteem Totally Implantable Hearing System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial

Resource links provided by NLM:


Further study details as provided by Envoy Medical Corporation:

Primary Outcome Measures:
  • SRT Improvement [ Time Frame: 4 Months Post Activation ] [ Designated as safety issue: No ]
    Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

  • SRT Improvement [ Time Frame: 10 Months Post-Activation ] [ Designated as safety issue: No ]
    Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

  • Word Recognition Score Improvement [ Time Frame: 4 Months Post Activation ] [ Designated as safety issue: No ]
    Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

  • Word Recognition Score Improvement [ Time Frame: 10 Months Post Activation ] [ Designated as safety issue: No ]
    Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

  • SADEs [ Time Frame: 10 Months Post-Activation ] [ Designated as safety issue: Yes ]
    The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements

  • Assessment of Cochlear Function [ Time Frame: 4 and 10 Months Post-Activation ] [ Designated as safety issue: Yes ]
    Comparison of the bone conduction threshold with forehead placement at the 4 month post-activation follow-up compared to the pre-implant bone conduction threshold.


Secondary Outcome Measures:
  • PTA Improvement [ Time Frame: 4 and 10 Months Post-Activation ] [ Designated as safety issue: No ]
    Comparison of the 3-frequency (500, 1000, and 2000 Hz) pure-tone average (PTA) using the Esteem System to the PTA measured in the baseline unaided condition

  • QuickSIN [ Time Frame: 4 and 10 Months Post-Activation ] [ Designated as safety issue: No ]
    To assess whether the Esteem System is as effective as or better than the pre-implant hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results.

  • APHAB [ Time Frame: 4 and 10 Months Post-Activation ] [ Designated as safety issue: No ]
    To assess whether the Esteem System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results

  • Esteem Questionnaire [ Time Frame: 4 and 10 Months Post Activatio- ] [ Designated as safety issue: No ]
    To gain subject feedback and comments on the use of the Esteem System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem Questionnaire.


Enrollment: 57
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esteem Implant
Subjects are implanted with the Esteem Totally Implantable Hearing System
Device: Esteem Totally Implantable Hearing System
The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 18 years old
  • Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
  • Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem System.
  • Subject has mild to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow:

Freq (Hz) 500 1000 2000 3000 4000 LL* (dB HL) 30 35 35 35 35 UL* (dB HL) 100 100 100 100 100

*LL = Lower Level; UL = Upper Level

  • Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz.
  • Subject has an unaided maximum word recognition score of greater than or equal to 60% with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at maximum tolerable presentation level.
  • Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid.
  • Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
  • Subject has normally functioning eustachian tube
  • Subject has normal tympanic membrane
  • Subject has a normal middle ear anatomy
  • Subject has adequate space for Esteem System implant determined via fine cut temporal bone CT scan
  • Subject is a native speaker of the English language.
  • Subject is a hearing aid user in the ear to be implanted.

Exclusion Criteria:

  • Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease
  • Subject has a history of otitis externa or eczema for the outer ear canal and the investigator believes this will affect the Esteem System implantation
  • Subject has cholesteatoma or destructive middle ear disease
  • Subject has life expectancy of two (2) years due to other medical conditions
  • Subject has retrocochlear or central auditory disorders
  • Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing
  • Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz)
  • Subject has sudden hearing loss due to unknown cause
  • Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
  • Subject is unable to adequately perform audiological testing
  • Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial.
  • Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial
  • Subject is pregnant at the time of device implant
  • Subject has a history of keloid formation
  • Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092910

Locations
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Shohet Ear Associates
Newport Beach, California, United States, 92663
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
United States, North Carolina
Surgical Care Affiliates
Greensboro, North Carolina, United States, 27401
The Ear Center of Greensboro
Greensboro, North Carolina, United States, 27401
Sponsors and Collaborators
Envoy Medical Corporation
Investigators
Principal Investigator: Jack A. Shohet, M.D.
Principal Investigator: Eric M. Kraus, M.D., M.S. F.A.C.S.
Principal Investigator: Peter J. Catalano, M.D. F.A.C.S.
  More Information

Additional Information:
Responsible Party: Envoy Medical Corporation
ClinicalTrials.gov Identifier: NCT01092910     History of Changes
Other Study ID Numbers: 0204 
Study First Received: March 19, 2010
Results First Received: January 26, 2016
Last Updated: January 26, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Envoy Medical Corporation:
Sensorineural
Hearing Loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Sensorineural
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016